Senior Regulatory Affairs Specialist
We are seeking a Senior Regulatory Affairs Specialist to join our growing medical device organisation.
Key Responsibilities:
* Manage the regulatory and vigilance process, ensuring compliance with relevant regulations.
* Prepare and submit regulatory submissions for required markets, coordinating input from stakeholders and tracking product clearances.
* Maintain technical files for cleared products, supporting continuous improvement of the Quality Management System.
* Support the Senior Quality & Regulatory Manager in managing product certification testing, risk management, and complaint handling.
* Stay up-to-date with changing regulatory requirements, including REACH, ROHS2, and FDA guidelines.
* Ensure environmental registrations and maintain labelling and packaging updates from a regulatory perspective.
* Conduct internal audits and lead CE technical file audits for the company.
Requirements:
* A third-level degree and significant experience in medical devices.
* Post-graduate qualification in Quality Assurance, preferably with experience in active medical devices.
* Significant regulatory affairs experience, including international regulatory processes.
* In-depth knowledge of product certification testing requirements and maintaining a certified Quality Management System.
* Knowledge of quality tools and methodologies, including Lean Six Sigma, TQM, and ISO13485.
* Experience with EN/MDD/MDR, FDA, and ISO standards.
* Trained QMS Internal Auditor and advanced Microsoft Office skills.